PKL · Hemostatic Metal Clip For The Gi Tract
Gastroenterology, Urology · 21 CFR 876.4400 · Class 2
Overview
| Product Code | PKL |
|---|---|
| Device Name | Hemostatic Metal Clip For The Gi Tract |
| Regulation | 21 CFR 876.4400 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.
Classification Rationale
Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 62)
Showing 20 most recent of 62 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252270 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Apr 8, 2026 | SESE |
| K253734 | Taurus Clip | Taurus Endoscopy | Mar 12, 2026 | SESE |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | Dec 18, 2025 | SESE |
| K252271 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Nov 12, 2025 | SESE |
| K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | Sep 8, 2025 | SESE |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | Apr 18, 2025 | SESE |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | Boston Scientific Corporation | Feb 6, 2025 | SESE |
| K241005 | Haemostasis Clips | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | Jan 2, 2025 | SESE |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | Sep 17, 2024 | SESE |
| K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | Aug 26, 2024 | SESE |
| K234124 | Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. | Jul 12, 2024 | SESE |
| K232969 | Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. | Jun 7, 2024 | SESE |
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | Jun 3, 2024 | SESE |
| K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | Mar 19, 2024 | SESE |
| K232450 | Disposable Hemostatic Clips | Zhejiang Soudon Medical Technology Co., Ltd. | Jan 26, 2024 | SESE |
| K231633 | Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | Jan 11, 2024 | SESE |
| K230004 | Disposable Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Jul 31, 2023 | SESE |
| K222146 | Disposable Endoscopic Hemoclip | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Mar 28, 2023 | SESE |
| K213217 | Disposable hemoclip | Beijing Zksk Technology Co., Ltd. | Nov 14, 2022 | SESE |
| K222503 | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | Boston Scientific Corporation | Sep 14, 2022 | SESE |
Top Applicants
- Boston Scientific Corporation — 8 clearances
- Micro-Tech (Nanjing) Co., Ltd. — 8 clearances
- Ovesco Endoscopy AG — 8 clearances
- Hangzhou AGS MedTech Co., Ltd. — 5 clearances
- STERIS Corporation — 4 clearances
